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The second objective was to evaluate the risk of infections during typical and repeated subcutaneous injections.\u200950 participants with diabetes and 50 controls (n\u2009=\u2009100) were sampled through tape strips and skin swabs on the abdomen and thigh for skin microflora. Used pen injectors and needles were collected after\u2009<jats:italic>in\u2010home<\/jats:italic>\u2009use and from the hospital after drug administration by health care professionals (HCPs). Samples were analyzed by conventional culture, matrix\u2010assisted laser desorption\/ionization\u2010time of flight (MALDI\u2010TOF), mass spectrometry (MS), confocal laser scanning microscopy (CLSM), and 16S\/ITS high throughput sequencing (HTS). A mathematical model simulated the risk of needle contamination during injections. Injection site populations were in 10<jats:sup>2<\/jats:sup>\u2009cells\/cm<jats:sup>2<\/jats:sup>\u2009order, with increased viable bacteria and anaerobic bacteria on the skin in persons with diabetes (p\u2009=\u20090.05).\u2009Interpersonal variation dominated other factors such as sex or location. A higher prevalence of\u2009<jats:italic>Staphylococcus aureus<\/jats:italic>\u2009on abdominal skin was found in persons with diabetes than control skin (p\u2009\u2264\u20090.05). Most needles and cartridges (95% and 86%) contained no biological signal. The location of the device collection (hospital vs home\u2010use) and use regimen did not affect contamination.\u2009CLSM revealed scarcely populated skin\u2009microflora scattered in aggregates, diplo, or single cells. Our mathematical model demonstrated that penetrating bacteria colonies during subcutaneous injection is unlikely.\u2009These findings clarify the lack of documented skin infections from subcutaneous insulin injections in research. Furthermore, these results\u2009can\u2009motivate the innovation and development of durable, reusable injection systems with pharmacoeconomic value and a simplified and enhanced user experience for patients.<\/jats:p>","DOI":"10.1111\/apm.13230","type":"journal-article","created":{"date-parts":[[2022,4,23]],"date-time":"2022-04-23T07:34:16Z","timestamp":1650699256000},"page":"404-416","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Injection site microflora in persons with diabetes: why needle reuse is not associated with increased infections?"],"prefix":"10.1111","volume":"130","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2382-4240","authenticated-orcid":false,"given":"Sofia","family":"Wareham\u2010Mathiassen","sequence":"first","affiliation":[{"name":"Department of Immunology and Microbiology Copenhagen University  Copenhagen Denmark"},{"name":"Department of Front\u2010End Innovation, Devices &amp; Delivery Solutions Novo Nordisk A\/S  Hiller\u00f8d Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4164-5900","authenticated-orcid":false,"given":"Lene","family":"Bay","sequence":"additional","affiliation":[{"name":"Department of Immunology and Microbiology Copenhagen University  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vera Pinto","family":"Glenting","sequence":"additional","affiliation":[{"name":"Department of Packaging &amp; Materials Development, Devices &amp; Delivery Solutions Novo Nordisk A\/S  Hiller\u00f8d Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naireen","family":"Fatima","sequence":"additional","affiliation":[{"name":"Department of Immunology and Microbiology Copenhagen University  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Henrik","family":"Bengtsson","sequence":"additional","affiliation":[{"name":"Department of SaMD Design control &amp; Engineering Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8003-7414","authenticated-orcid":false,"given":"Thomas","family":"Bjarnsholt","sequence":"additional","affiliation":[{"name":"Department of Immunology and Microbiology Copenhagen University  Copenhagen Denmark"},{"name":"Department of Clinical Microbiology Rigshospitalet  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,5,17]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.4103\/2230-973X.176456"},{"key":"e_1_2_9_3_1","unstructured":"Insulin Pens Market Size Share Trends Growth\u00a62022 to 2027. 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